Science and Enterprise

Tag: FDA

  • Clinical Trial of Embryonic Stem Cell Therapy Authorized

    Geron Corporation of Menlo Park, California said today that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s investigational new drug and its Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury may proceed. GRNOPC1 is Geron’s lead human embryonic stem cell (hESC)-based candidate.…

  • Acute Radiation Syndrome Drug Granted FDA Fast Track Status

    Cleveland BioLabs Inc., a biotechnology company in Buffalo, New York, today announced that CBLB502, a drug developed for the treatment of acute radiation syndrome (ARS), has been granted fast track status by the U.S. Food and Drug Administration (FDA). CBLB502 is derived from a microbial protein that can reduce injury from acute stresses, such as…

  • Cosmetics Group Calls for More FDA Oversight of Ingredients

    A cosmetics and personal care products trade group on Friday called for the U.S. Food and Drug Administration (FDA) to play a larger role in assessing the safety of ingredients used in their products. The Personal Care Products Council says it favors establishment of formal processes for FDA to review ingredients for safety at the…

  • Genzyme to Expand its Suburban Boston Campus

    Genzyme Corporation, a biotech company in Cambridge, Massachusetts, plans to double the size of its manufacturing and research facilities in nearby Framingham, according to a story by Scott Van Voorhis in yesterday’s Boston Globe. The plan involves doubling the size of that facility and adding up to 1,000 new jobs, according to a company executive…